This study is looking at Acute Myeloid Leukemia, which is a type of blood cancer that affects the bone marrow and blood cells. The study is for people who cannot receive strong chemotherapy treatment because of their age or other health problems. The study will use two medications: venetoclax, which comes as tablets taken by mouth, and azacitidine, which is given as an injection under the skin, into a vein, or into a muscle. Some people in the study will also receive a placebo.
The purpose of this study is to compare two different ways of giving venetoclax together with azacitidine. One group of people will take venetoclax for only seven days during each treatment cycle, while the other group will take venetoclax continuously for the full cycle of twenty-eight days. Both groups will receive azacitidine. The study wants to find out if taking venetoclax for a shorter time works as well as taking it for the full cycle in terms of putting the leukemia into remission, which means reducing or eliminating the cancer cells. This will be measured by looking at whether people achieve complete remission or complete remission with incomplete recovery of the bone marrow during the first six treatment cycles.
During the study, people will receive their assigned treatment in repeated cycles. Each cycle lasts twenty-eight days, and people may continue treatment for multiple cycles depending on how well the treatment works and how well they tolerate it. The study will monitor how well the treatment controls the leukemia, how long people live, and what side effects occur. The study will also look at quality of life and how the different treatment schedules affect the need for blood transfusions, infections, and hospital stays. The total treatment period can last up to one hundred sixty-eight days for venetoclax and up to forty-two days for azacitidine.
France 
Spain 
